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| Sponsor: | Hemispherx Biopharma |
|---|---|
| Information provided by (Responsible Party): | Hemispherx Biopharma |
| ClinicalTrials.gov Identifier: | NCT00215813 |
Purpose
This is an open label study of Ampligen in patients with chronic fatigue syndrome.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Fatigue Syndrome |
Drug: Ampligen (poly I: poly C12U) Drug: Poly I: Poly C12U |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-Label Study Of Poly I:Poly C12U (AMPLIGEN®)IN Patients With Severely Debilitating Chronic Fatigue Syndrome (CFS) |
| Estimated Enrollment: | 100 |
| Study Start Date: | March 1997 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Poly I: Poly C12U |
Drug: Ampligen (poly I: poly C12U)
200-400 mg IV infusion given twice weekly for 30-60 minutes
Drug: Poly I: Poly C12U
200-400 mg IV infusions given twice weekly over a period of 30-60 minutes
|
An Open-Label Study of Poly I: Poly C12U (Ampligen®) in Patients with Severely Debilitating Chronic Fatigue Syndrome (CFS)/Myalgic Encephalomyelitis (ME). The FDA approved the study for cost recovery. Patients enrolled in the study are responsible for costs related to the therapy, e.g., drug cost, infusion cost, cost of supplies, diagnostic and other laboratory testing.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Diane Young | 732-2493250 ext 609 | diane.young@hemispherx.net |
| Contact: Ann Marie Coverly | 215-988-0080 ext 115 | annmarie.coverly@hemispherx.net |
| United States, Florida | |
| Chronic Fatigue Center | Recruiting |
| Miami, Florida, United States, 33176 | |
| Contact: Hannah Olanoff 305-595-4300 holanoff@cfsclinic.com | |
| Principal Investigator: Nancy Klimas, MD | |
| United States, Nevada | |
| Dr. Daniel Peterson | Recruiting |
| Incline Village, Nevada, United States, 89451 | |
| Contact: Kathleen Colley 775-832-0989 kathleen@ishere.com | |
| Principal Investigator: Daniel Peterson, MD | |
| United States, New York | |
| Dr. Derek Enlander | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Laura Melilli 212-794-2000 enlandercfs@yahoo.com | |
| Principal Investigator: Derek Enlander, MD | |
| United States, North Carolina | |
| Hunter-Hopkins Center, PA | Recruiting |
| Charlotte, North Carolina, United States, 28210 | |
| Contact: Wendy Fallick 704-543-9692 | |
| United States, Utah | |
| The Fatigue Consultation Clinic | Recruiting |
| Salt Lake City, Utah, United States, 84102 | |
| Contact: Ali Allen ali@fcclinic.com | |
| Principal Investigator: | Daniel Peterson, M.D. | Sierra Internal Medicine |
| Principal Investigator: | Lucinda Bateman, M.D. | Fatigue Consultation Clinic |
| Principal Investigator: | Charles W. Lapp, M.D. | Hunter-Hopkins Center, P.A. |
| Principal Investigator: | Nancy Klimas, M.D. | Chronic Fatigue Center |
| Principal Investigator: | Derek Enlander, MD | Private Practice CFIDS Fibromyalgia & CFS |
More Information
| Responsible Party: | Hemispherx Biopharma |
| ClinicalTrials.gov Identifier: | NCT00215813 History of Changes |
| Other Study ID Numbers: | AMP 511 |
| Study First Received: | September 16, 2005 |
| Last Updated: | September 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Chronic Fatigue Syndrome CFS ME Ampligen poly I:poly C12U |
|
Fatigue Fatigue Syndrome, Chronic Signs and Symptoms Virus Diseases Muscular Diseases Musculoskeletal Diseases Encephalomyelitis Central Nervous System Diseases Nervous System Diseases Neuromuscular Diseases |
Poly I-C Ampligen Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Interferon Inducers Immunologic Factors Physiological Effects of Drugs |